Fluid containing endoluminal stent

ABSTRACT

An endoluminal stent contains a hollow passageway for the circulation of fluids to treat vascular walls affected with malignant growths or experiencing restenosis. The hollow passageway stent can have one or a plurality of passageways and is configured in a tubular shape with numerous coils, providing an empty tubular lumen through the center of the stent to allow blood flow. The stent is connected to a removable catheter that conducts fluid to the stent. Fluid flow may be regulated by valves incorporated in either the stent and/or the catheter. The stent and catheter are connected to avoid leakage of the fluid. Cryogenic, heated or radioactive fluids are circulated through the stent to treat the affected sites. A method of delivering drugs to the vascular wall is also provided by creating a stent with porous outer walls to allow diffusion of the drug.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a division of application Ser. No.09/321,496, filed May 27, 1999, which claims the benefit of U.S.Provisional Application No. 60/105,768, filed Sep. 30, 1998, each ofwhich are incorporated fully herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to endoluminal devices,and more particularly to stents.

BACKGROUND OF THE INVENTION

[0003] Stents and similar endoluminal devices have been used to expand aconstricted vessel to maintain an open passageway through the vessel inmany medical situations, for example, following angioplasty of acoronary artery. In these situations, stents are useful to preventrestenosis of the dilated vessel through proliferation of vasculartissues. Stents can also be used to reinforce collapsing structures inthe respiratory system, the reproductive system, biliary ducts or anytubular body lumens. Whereas in vascular applications fatty deposits or“plaque” frequently cause the stenosis, in many other body lumens thenarrowing or closing may be caused by malignant tissue.

[0004] Fluids have traditionally been used to pressurize the angioplastyballoons used to open restricted vessels. The balloons may have avariety of shapes including a coiled form. In such a device fluid isinjected into the balloon to inflate the device and maintain turgidity.Shturman (U.S. Pat. No. 5,181,911) discloses a perfusion ballooncatheter wound into a helically coiled shape with one end attached to afitting and the other to a syringe for inflating the balloon with fluid.When the balloon is inflated, its coiled form allows blood flow thoroughthe open center of the structure. At the same time it is possible toactually have fluid flow within the balloon structure so that thesyringe can deliver fluid into the balloon, fluid can flow through theballoon, and fluid can then exit through a second lumen in a catheterattached to the syringe.

[0005] Coiled stents that are connected to a catheter apparatus, as inWang et al. (U.S. Pat. No. 5,795,318), are used for temporary insertioninto a patient. Wang et al. discloses a coiled stent of shape-memorythermoplastic tube that can be converted from a relatively narrowdiameter to a larger coiled form by heating. The narrow diameter coil ismounted at the end of a catheter over a balloon and in a preferredembodiment a resistive heating element runs down the length of thethermoplastic element. An electric current is applied to heat theelement thereby softening it while the balloon is expanded to enlargethe diameter of the coil. Upon cooling the enlarged coil hardens and theballoon is withdrawn. After the temporary stent has performed its duty,it is again heated and removed while in the softened state. In oneembodiment the thermoplastic tube is supplied with an additional lumenso that liquid drugs can flow into the stent and delivered throughapertures or semi-permeable regions.

[0006] The attempt to kill or prevent proliferation cells is a commontheme in clinical practice. This is generally true in vascular andnon-vascular lumens. It is known that ionizing radiation can preventrestenosis and malignant growth. Although the effect of temperatureextremes, e.g., cryogenic (cold) or hot temperatures, on cellularactivity is not as well researched, it may provide a safer approach tocontrol of tissue proliferation. Among the drawbacks of the prior artcoiled balloons is that the balloon material is relatively weak so thatexpansion and contraction cause the balloon to fail. Failure of aballoon containing radioactive or cryogenic fluids could becatastrophic. It would be desirable to provide a catheter based,minimally invasive device for stenting support that could deliver hot orcryogenic or radioactive fluids or drugs and that would be sturdy andcould remain in the body for extended periods of time, detached from theinsertion device.

BRIEF SUMMARY OF THE INVENTION

[0007] In its simplest embodiment the present invention is anendoluminal coil stent comprising a hollow tube formed into a series ofloops or other known stent shapes which initially has a low profile anddiameter. This structure can be delivered into a patient's vascularsystem and expanded to full size. The present invention to provides astent that is hollow allowing the passage of fluid. The stent has eitherone or a plurality of passageways for fluid flow. The stent is attachedto a catheter via a special fitting so that when engaged with thecatheter, fluid flows freely from the catheter to the stent with apossible return circuit through the catheter. When disengaged, thefitting prevents leakage from the stent permitting the stent to remainin place in a patient's vasculature.

[0008] This invention provides a way of treating vascular areas affectedwith malignant growths or experiencing restenosis from smooth musclecell proliferation, etc. The stent is inserted in a small diameterconfiguration and after being enlarged to a larger diameter, acts as asupport device for the areas of restenosis or malignant growth. Inaddition, the stent can treat these affected areas in a unique way byflowing radioactive, heated or cryogenic fluids through the stent.

[0009] The present invention also provides a way of delivering drugs toan affected site. A stent to accomplish this purpose can be composed ofseveral different materials. For example, the stent can formed from ametal or other material with small pores machined or otherwise formed(e.g., with a laser). When such a stent is filed with a drug, that drugslowly disperses through the pores. Alternatively, an entire metal tubeor portions of the tube could be formed e.g., from sintered metal powderthereby forming a porous structure for drug delivery. Another embodimentwould alternate a metal tube (for structural stability) with dispensingsegments inserted at various intervals. The segments would be perforatedto allow seepage of the drug or would be otherwise formed from a porousmaterial. Another embodiment employs an expanded polytetrafluoroethylene(PTFE) tube around a support wire or metal tube in the form of a coiledstent so that a hollow passageway is created between the metal and thePTFE. A drug is flowed into this space and slowly dispensed through theporous PTFE.

[0010] One embodiment of the hollow stent of the present inventioncomprises a shape memory metal such as nitinol. Shape memory metals area group of metallic compositions that that have the ability to return toa defined shape or size when subjected to certain thermal or stressconditions. Shape memory metals are generally capable of being deformedat a relatively low temperature and, upon exposure to a relativelyhigher temperature, return to the defined shape or size they held priorto the deformation. This enables the stent to be inserted into the bodyin a deformed, smaller state so that it assumes its “remembered” largershape once it is exposed to a higher temperature (i.e. body temperatureor heated fluid) in vivo.

[0011] Special fittings are incorporated at the ends of the hollowstent. These fittings facilitate the injection and removal of fluid andalso allow the stent to be detached from the insertion device to be leftin place in a patient. The hollow stent has an inlet and an outlet sothat a complete fluid path can be created, and fluid can be continuallycirculated through the stent. In the simplest configuration the inletand outlet are at opposite ends of the stent. However, if the stent isequipped with a plurality of lumens, two lumens can be connected at adistal end of the structure so that the outlet and inlet are bothtogether at one end. Other arrangements can be readily envisioned by oneof ordinary skill in the art.

[0012] The stent is inserted into the body while connected to a catheterin a small, deformed state. Once inside the patient's body the stent isadvanced to a desired position and expanded to its larger full size. Ifthe stent is composed of shape memory metal, for example, the stentexpands from its small-deformed state to its remembered larger state dueto the higher body temperature or due to the passage of “hot” fluidthrough the stent. Subsequently “treatment” fluid (e.g., heated,cryogenic or radioactive) is pumped through the catheter to the stentwhere it is circulated throughout the stent, treating the adjacentvascular walls. The catheter can either be left in place for a certainperiod of time or removed, leaving the fluid inside the stent. Thiswould particularly be the case with radioactive fluid or with a porousdrug delivery stent.

[0013] The stent can be removed by reattaching the catheter allowing oneto chill and shrink the stent (in the case of a memory alloy).Alternatively, the device can readily be used in its tethered form toremove memory alloy stents of the present invention or of prior artdesign. For this purpose a device of the present invention is insertedinto the vasculature to rest within the stent to be removed. Warm fluidis then circulated causing the stent to expand into contact with thememory alloy stent that is already in position. At this point cryogenic(e.g., low temperature) fluid is circulated causing the attached stentand the contacted stent to shrink so that the combination can be readilywithdrawn.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014]FIG. 1 is a perspective view of a hollow coiled stent.

[0015]FIG. 2 is a perspective view of a valve assembly to be used withFIG. 1.

[0016]FIG. 3 is a sectional view of the hollow stent tube of FIG. 2.

[0017]FIG. 4 is a representation of the stent of FIG. 1 in the positionfor treatment.

[0018]FIG. 5 is a sectional view of a second embodiment of a hollowcoiled stent.

[0019]FIG. 6 is a perspective view of a second embodiment of a hollowcoiled stent.

[0020]FIG. 7 is a perspective view of a third embodiment of a hollowcoiled stent.

[0021]FIG. 8 is a perspective view of a valve assembly to be used withFIG. 6.

[0022]FIG. 9 is a perspective view of a fourth embodiment of a hollowcoiled stent.

[0023]FIG. 10 is a sectional view of the hollow stent tube of FIG. 8.

[0024]FIG. 11 (11 a, 11 b, and 11 c) is an illustration of the methoddetailed in FIG. 12.

[0025]FIG. 12 is a flow diagram explaining use a stent of the presentinvention to retrieve a shape memory stent already in place.

DETAILED DESCRIPTION OF THE INVENTION

[0026] Referring now to the drawings, in which like reference numbersrepresent similar or identical structures throughout the drawings, FIG.1 depicts a preferred embodiment of this invention. Pictured in FIG. 1is a medical apparatus 10 comprising an endoluminal stent 20 attached toa delivery catheter 30 by means of a valve assembly 40. In thisrepresentation endoluminal stent 20 is generally coiled in shape leavinga tubular space down the center of its length. Obviously, the principleof a hollow stent can be applied to stents of a zigzag or otherconstruction other than simply coiled. The tubing 22 of the stent 20 ispreferably composed of a metal material that can be crimped onto aballoon catheter (not shown) for insertion into a body. Once positionedinside of the body at the desired location, the balloon can be inflated,bringing the stent from a compact small size to its enlarged full sizethus opening a pathway for blood flow.

[0027] Inside the tubing 22 of stent 20, two fluid pathways exist. Thesepathways can be seen in the cross sectional view of FIG. 3. Pathways 26and 28 have opposite flowing fluid streams and connect at the distal end24 of stent 20. By allowing for opposite streams, radioactive, heated orcryogenic liquids can continuously flow through stent 20 for the purposeof killing or preventing proliferation of cells. By “heated” or “hot” ismeant temperatures above body temperature. By “cryogenic” or “cold” ismeant temperatures below body temperature. The stent 20 can eitherremain connected to a delivery catheter 30 for temporary insertion, orbe detached for a more permanent insertion. In either case, fluid flowcan be circulated throughout stent 20 prior to disconnection. In thesimplest design, fluid passageways connected to the stent 20 are lumensof the delivery catheter so that when the catheter is withdrawn, fluidflow must cease. It is also possible to provide separate flexible tubesthat are threaded through the catheter so that the delivery catheter canbe withdrawn leaving the relatively smaller fluid delivery tubes (notshown) behind. Preventing leakage of the fluid from the stent 20 afterthe catheter 30 is disconnected is accomplished through a valvemechanism contained in the catheter 30, or the stent 20 and/or both. Inthe example illustrated in FIG. 2 rubber or elastomer diaphragms 25 arepenetrated by small hollow needles 48 in the valve assembly 40. Inaddition, the valve 40 may comprise a simple back flow preventer. Thus,when pressure is applied from incoming fluid to the valve assembly 40, aball 45 which sits in a ball seat 44 is forced back against a spring 46and the valve 40 opens for the incoming fluid pathway 28. A similararrangement allows pressure to open the outgoing fluid pathway 26. Acheck ball valve is shown only as an example. Flap valves or any of anumber of other back flow valve designs well known in the art can beemployed. Complex systems in which a bayonet-type attachmentautomatically opens a valve are also possible.

[0028] The catheter 30 comprises a catheter shaft 32, which furthercontains two fluid pathways 34 and 36 as seen in FIG. 2. At the distalend of catheter 30, the valve assembly 40 has small hollow needles 48that are designed to puncture elastomer diaphragms 25. The catheter 30is slightly larger in diameter than the stent member 20 so that thecatheter tubing wall 32 forms a friction fit over the stent wall 22.This creates a seal between the catheter 30, and the stent 20 for fluiddelivery and removal. Upon detaching the catheter 30 leakage from thestent 20 is prevented due to the self-healing properties of thediaphragms 25. Obviously, the back flow preventer 40 could be on thestent 20 and the diaphragms could be on the catheter 30.

[0029] As discussed above, stent 20 is inserted into the body to thedesired site through the use of a catheter insertion device well knownin the art. FIG. 4 depicts stent 20 in its enlarged form after it hasbeen inserted into the body at the affected location and expanded. Othermeans of stent expansion other than a balloon catheter are possible. Ifthe stent 20 is formed from shape memory metal, such as Nitinol, theheat of the body can cause the stent 20 to assume a larger, rememberedform. Alternatively, heated fluid can be circulated through the stent tocause it to recover its remembered form. A self-expanding stent made ofa spring-type alloy can also be employed. In that case the deliverycatheter would be equipped with means (e.g., an outer sheath) to keepthe stent compressed until it was at the desired location.

[0030] By increasing the diameter of stent 20 at an affected location,the passageway is enlarged to permit increased blood flow. At the sametime, fluids can pass through the interior of tubes 22 of the hollowstent 20 to treat the vascular wall. The walls of the vasculature can betreated by running either a radioactive, cryogenic or heated fluidthrough the stent 20 or by delivering a drug through a stent equippedfor drug diffusion (e.g., through holes or a porous region).

[0031]FIG. 5 depicts a second embodiment of the invention. In thisembodiment, the hollow stent 60 has only one fluid pathway 66, an inletwithout an outlet, and is used to deliver drugs to affected areas. Oncethe stent 60 is inserted into place and is in its enlargedconfiguration, drugs are delivered through the catheter to the stent 60.Stent 60 can be constructed in various ways to facilitate the deliveryof drugs. In one case, as shown in FIG. 6, the stent 60 is constructedwith regions or segments that have pores 64 to allow drug seepage fromthe tubing 62. Alternatively, continuously porous metal, porous plastic,or a combination of metal and plastic can be used. The perforations 64or slits in the stent to facilitate drug delivery must be ofsufficiently small size to allow the passage of the drug through theentire length of the stent so that all areas can be treated. It will beapparent that pore size can control the rate at which the drug isdispensed. It is possible to cover the pores 64 with semi-permeablemembrane to further control and restrict drug outflow. A semi-permeablemembrane with inclusion of an osmotic agent with the drug will result inwater uptake and more rapid and controlled pressurized delivery of thedrug.

[0032] A third embodiment of the invention, FIG. 7, has a hollow stent70 containing a single fluid pathway. The tubing 72 can be made of anyof the materials discussed above, but in this embodiment, the stent 70has an inlet path 78 that carries the fluid to the distal end 74 ofstent 70 where it then runs through the coils. In this embodiment, avalve 80 connects the stent 70 to catheter 30. FIG. 8 shows across-sectional view of valve 80. The pressure from the liquid sentthrough the catheter causes the gate 82 of valve 80 to open to allow thefluid into the inlet path 78. The pressure that forces the opening ofgate 82 causes the simultaneous opening of gate 84, allowing the fluidthat is circulated through the stent 70 to exit through pathway 36 ofcatheter 30. The fluid entering and exiting through catheter 30 mustalso go through a check ball valve assembly similar to the one shown inFIG. 2. Again, flaps or other “one way” valve mechanisms can be applied.After all incoming fluid has been delivered to the stent 70, the absenceof pressure causes gate 82 and gate 84 to close, thereby closing valve80. This design can be used with any of the fluids mentioned above. Thestent 70 can be used to circulate radioactive or cryogenic fluids fortreatment of the vascular walls and can also be perforated for thedelivery of drugs.

[0033] In a fourth embodiment, a hollow coiled stent 90 is formed frompolytetrafluoroethylene (PTFE) 92. In FIG. 9, a perspective view of thisembodiment can be seen. The stent 90 consists of a support wire 94 overwhich PTFE 92 is fitted. The pliable structure resulting is then formedinto a coiled stent. The PTFE 92 is fitted around the wire 94 so thatthere is sufficient room to allow the passage of fluid. FIG. 10 shows across-sectional view of stent 90, illustrating the pathway 96 createdaround the support wire 94 to allow the passage of fluid. In thisembodiment, stretched expanded PTFE can be used to create a porous stentto facilitate the delivery of drugs. The wire 94 can also be hollow(passageway 95) so that the stent 90 can simultaneously deliver drugsand radioactive fluid or temperature regulating fluid.

[0034] A fifth embodiment of the invention is illustrated in FIG. 11 anddescribed in a flow diagram shown in FIG. 12. This embodiment is amethod for recapturing an existing shape memory metal stent already inthe body. With reference to both FIGS. 11 and 12, a shape memory metalstent A is inserted into the body in its small, deformed state throughthe use of an insertion device well known in the art in step 112. Theinserted stent A in its deformed state is placed into the center of amemory alloy stent B that is already in an enlarged support position inthe body in step 114. The deformed stent A is then enlarged so that itcomes in contact with stent B. This can be accomplished in one of twoways. Either the stent A may enlarge due to the higher in vivo bodytemperature in step 115, or a hot liquid may be pumped through stent Ato cause it to expand in step 116. Once expanded and in contact withstent B, cryogenic liquid may be pumped through stent A so that bothstent A and stent B are chilled and either shrink down to their deformedstates or become sufficiently relaxed to allow ready removal in step118. Once in a small, deformed or relaxed state, stents A and B areeasily removed from the body in step 119 by withdrawing the catheterattached to stent A. FIG. 11a illustrates stent A in its reduced statebeing inserted into stent A. FIG. 11b shows an enlarged version of stentA contacting stent B. Thereafter, a temperature change caused, forexample, by fluid circulating through stent A will shrink both stentsand enable their removal (FIG. 11c).

[0035] Having thus described a preferred embodiment of a hollowendoluminal stent, it should be apparent to those skilled in the artthat certain advantages of the within system have been achieved. Itshould also be appreciated that various modifications, adaptations, andalternative embodiments thereof may be made within the scope and spiritof the present invention. For example, a hollow stent with a coiled,tubular shape has been illustrated, however, many other possibilitiesexist for the shape and size of the hollow stent. In addition, thepassageways are illustrated as round but could take on a variety ofother shapes. The described embodiments are to be consideredillustrative rather than restrictive. The invention is further definedby the following claims.

We claim:
 1. A method of recapturing a shape memory stent that has beendeployed within a patient, wherein a lumen for the flow of blood iscreated by the deployed shape memory stent, comprising the steps of:inserting a recapture stent within the shape memory stent, wherein therecapture stent is attached to a catheter; enlarging the recapture stentto come in contact with the shape memory stent; cooling the recapturestent thereby reverting the shape memory stent to a smaller or relaxedstate whereby the shape memory stent enfolds the recapture stent; andwithdrawing the catheter to remove the recapture stent and shape memorystent.
 2. The method according to claim 1, wherein the recapture stentis comprised of non-inflatable non-porous tubing, having at least onefluid flow conduit therein, and wherein the enlarging step furthercomprises the step of circulating heated fluid through the fluid flowconduit.
 3. The method according to claim 1, wherein the recapture stentis comprised of non-inflatable non-porous tubing, having at least onefluid flow conduit therein, and wherein the cooling step furthercomprises the step of circulating cryogenic fluid through the fluid flowconduit.
 4. A method of treating a vascular wall, comprising the stepsof: providing a stent comprised of non-inflatable tubing, having atleast one fluid flow conduit therein and at least one porous region inan outer wall thereof; providing a removable catheter having a distalend that is sealingly attachable to the stent and valve means forcontrolling the flow of fluid; attaching the catheter to the stent;inserting the stent and catheter into a body, positioning the stent at adesired location in a body lumen; and delivering a treatment fluidthrough the catheter to the stent, wherein the treatment fluid isreleased through the porous region of the stent.
 5. The method accordingto claim 4, wherein the treatment fluid is a cryogenic fluid.
 6. Themethod according to claim 4, wherein the treatment fluid is a heatedfluid.
 7. The method according to claim 4, wherein the treatment fluidis a radioactive fluid.
 8. The method according to claim 4, wherein thetreatment fluid is a drug.
 9. A method of treating a vascular wall,comprising the steps of: providing a stent comprised of non-inflatabletubing, wherein the tubing comprises at least one fluid flow conduitwithin an outer wall thereof, at least one porous region in the outerwall and valve means for controlling the flow of fluid; providing aremovable catheter having a distal end that is sealingly attachable tothe stent; attaching the catheter to the stent; inserting the stent andcatheter into a body, positioning the stent at a desired location in abody lumen; and delivering a treatment fluid through the catheter to thestent, wherein the treatment fluid is released through the porous regionof the stent.
 10. The method according to claim 9, wherein the treatmentfluid is a cryogenic fluid.
 11. The method according to claim 9, whereinthe treatment fluid is a heated fluid.
 12. The method according to claim9, wherein the treatment fluid is a radioactive fluid.
 13. The methodaccording to claim 9, wherein the treatment fluid is a drug.